The Predictive Value of Dobutamine Echo-stress in the Clinical Response to CCM Therapy in Advanced HF
Recruiting · NCT06973902 · Observational (researchers observe without assigning treatment) · Lead sponsor: Quovadis Associazione
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational cohort study, which is both retrospective and prospective, is to evaluate the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) treatment in adult subjects suffering from symptomatic heart failure (HF) due to systolic left ventricular dysfunction, despite adequate medical therapy. Based on the response to stress echocardiography with preimplantation low-dose Dobutamine, the main questions it aims to answer are: * What is the proportion of subjects who experience a clinical response to CCM therapy at 12 months (NYHA reduction ≥ 1 class)? * There was a reduction in the number of hospitalizations, visits to the Emergency Department, and access to day hospital facilities for more than 4 hours compared to the year before the study (e.g., by intravenous infusion of cardiac inotropic drugs)? * What is the estimated change in the quality-of-life score using the "Quality of Life Questionnaire with Heart Failure - Minnesota" (MLHFQ) between baseline and the end of follow-up? * What is the change in walking distance between baseline and the end of the follow-up in the walk test (6MWT) (optional)? * What is the difference in NT-proBNP levels between baseline and the end of follow-up? Participants are already receiving CCM support as part of their regular medical care for heart failure.
Who can take part
Inclusion criteria
- Subject of both sexes with age ≥ 18 years,
- Ability to understand and sign informed consent to participate in the study and consent to process sensitive personal data.
- Carrier of symptomatic heart failure, despite optimal medical therapy (OMT),
- Reduced left ventricular systolic function (E.F. \<50%),
- It was positively evaluated for implanting a system for cardiac contractility modulation (CCM) (according to the European Society of Cardiology 2021 Guidelines on heart failure and the provisions of the C.E. mark approval)13.
- Have presented at least one hospitalization, access to the Emergency Department, or access to day hospital facilities for more than 4 hours (e.g., by intravenous infusion of cardiac inotropic drugs) in the year before implantation
Exclusion criteria
- Life expectancy \< 1 year due to non-cardiac comorbidities that reduce prognosis,
- Presence of contraindications to the CCM implantation procedure (absence of vascular access usable for CCM implantation, active infectious processes, active severe coagulopathies, presence of mechanical tricuspid valve),
- Contraindications to the performance of the echocardiographic test under pharmacological stress (heart failure in progress, myocardial infarction in the acute phase, acute inflammatory processes of the heart muscle and/or pericardium, critical aortic valve stenosis and severe obstructions to left ventricular outflow, dissecting aneurysm of the aorta, severe arrhythmias not controlled by therapy, known hypersensitivity to the drug, intraventricular thrombi).
Where it is running
13 locations listed.
- UOC Cardiologia con UTIC, Osp. Di Venere - Bari, Italy
- UO Cardiologia, S. Maria della Misericordia Hospital, ULSS5 Polesana - Rovigo, Italy
- PO Anastasia Guerriero, Marcianise (CE), UOC Cardiologia - Marcianise, Campania, Italy
- Clinica Montevergine, Mercogliano (AV), Laboratorio di Elettrofisiologia - Mercogliano, Campania, Italy
- UOC Cardiologia, Osp. San Rocco, Sessa Aurunca (CE), ASL Caserta - Sessa Aurunca, Campania, Italy
- Policlinico S.Orsola, UO Cardiologia - Bologna, Emilia-Romagna, Italy
- OSPEDALE CASTELLI, UO Cardiologia - Anzio, Lazio, Italy
- Elettrofisiologia e Aritmologia, ASST FBF Sacco - Milan, Lombardy, Italy
- Fondazione Giglio, Cefalù (PA), UOC Cardiologia - Cefalù, Sicily, Italy
- Osp. Generale Provinciale Mazzoni, UO Cardiologia - Ascoli Piceno, The Marches, Italy
- UOC Cardiologia, Osp. Di Mirano, ULSS 3 Serenissima - Mirano, Veneto, Italy
- UOC Cardiologia, Osp. Di Piove di Sacco (PD), ULSS 6 Euganea - Piove di Sacco, Veneto, Italy
- UOC Cardiologia, Osp. S.Bortolo, Vicenza, ULSS 8 Berica - Vicenza, Veneto, Italy